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Procedure

Surgical vs. Lifestyle Interventions for Type 2 Diabetes (TRIABETES Trial)

N/A

Waitlist Available

Led By Anita P Courcoulas, MD, MPH

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willingness to be randomized to a surgical intervention

For potential subjects with BMI 35 to 40 kg/m2: T2DM confirmed by either a documented fasting blood glucose > 126 mg/dl OR treatment with an anti-diabetic medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months, 1 year

Awards & highlights

TRIABETES Trial Summary

This trial is being done to compare the effectiveness of two types of bariatric surgery against an intensive lifestyle intervention in promoting weight loss and improvements in Type 2 diabetes in moderately obese patients.

Who is the study for?

This trial is for adults aged 25-55 with Type 2 diabetes and mild to moderate obesity (BMI between 30-40 kg/m2). Candidates should be willing to undergo surgery or a lifestyle intervention, have difficulty controlling diabetes medically, and not smoke. Exclusions include prior bariatric surgery, poor health, substance addiction, current pregnancy or research participation.Check my eligibility

What is being tested?

The study compares the effectiveness of two bariatric surgeries—Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding—with an intensive lifestyle weight loss program in improving Type 2 diabetes in moderately obese patients.See study design

What are the potential side effects?

Potential side effects from the surgical interventions may include nutritional deficiencies, gastrointestinal issues like nausea or vomiting, surgical complications such as infections or bleeding. The lifestyle intervention could lead to muscle strains or stress injuries from increased physical activity.

TRIABETES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to undergo surgery if randomly selected.

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I have a BMI between 35 and 40 and either have high fasting blood sugar or am on diabetes medication.

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I am between 25 and 55 years old.

TRIABETES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of performing a randomized trial comparing two major types of bariatric surgery versus a lifestyle weight loss intervention (LWLI) induced by diet and increased physical activity in moderately obese patients with T2DM.

Secondary outcome measures

Preliminary information regarding the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.

TRIABETES Trial Design

3Treatment groups

Experimental Treatment

Group I: Roux-en-Y Gastric Bypass SurgeryExperimental Treatment1 Intervention

Roux-en-Y Gastric Bypass Surgery

Group II: Lifestyle/Behavioral Weight LossExperimental Treatment1 Intervention

Lifestyle Weight Loss Intervention

Group III: Laparoscopic Adjustable Gastric BandingExperimental Treatment1 Intervention

Laparoscopic Adjustable Gastric Banding

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Roux-en-Y Gastric Bypass Surgery

2014

N/A

~30

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,726 Previous Clinical Trials

16,305,674 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,705 Previous Clinical Trials

7,507,217 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,364 Previous Clinical Trials

4,315,333 Total Patients Enrolled

Media Library

Laparoscopic Adjustable Gastric Banding (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT01047735 — N/A

Type 2 Diabetes Research Study Groups: Laparoscopic Adjustable Gastric Banding, Roux-en-Y Gastric Bypass Surgery, Lifestyle/Behavioral Weight Loss

Type 2 Diabetes Clinical Trial 2023: Laparoscopic Adjustable Gastric Banding Highlights & Side Effects. Trial Name: NCT01047735 — N/A

Laparoscopic Adjustable Gastric Banding (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01047735 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently allowed to enroll in this experiment?

"According to the information found on clinicaltrials.gov, this medical experiment is not currently recruiting participants. Although it was initially posted in September 2009 and last modified in August 2022, there are over 2300 other trials that are actively searching for volunteers right now."

Answered by AI

Who is qualified to participate in this scientific research?

"Eligibility for this prospective study requires diabetes mellitus and a age range of 25 to 55 years. Currently, the recruitment program is searching for 69 participants in total."

Answered by AI